LVivo Seamless
K243331DiA Imaging Analysis Ltd. · cleared 2025-03-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment.”
source quote (p.5)
“The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 3rd party software.”
Validation studies (1)
Retrospective clinical
n=166 cases
endpoints: Automatic processing based on correctly identified 4 chamber, 2 chamber and 3 chamber views; Correlation between Ground Truth Biplane EF measurements and automated Biplane EF results; Correlation between Ground Truth GLS measurements and automated GLS results; Pearson's Correlation; Bland Altman
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).